Arimidex/Tamoxifen Neo Adjuvant Study in Premenopausal Patients With Breast Cancer Under Anti Hormonal Treatment

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Anastrazole (Arimidex); Drug: Goserelin acetate (Zoladex); Drug: Tamoxifen

Study type: Interventional

Funder types: Industry

Identifiers

NCT00605267

D539BC00001

Details and patient eligibility

About

The purpose of this multi-centre, randomised, double-blind, parallel-group study is to compare efficacy and safety between anastrozole and tamoxifen in pre- and post-operative administration under goserelin acetate treatment for premenopausal breast cancer patients

Enrollment: 197 patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Premenopausal, estrogen receptor positive women, aged 20 years and over, with operable and measurable breast cancer who have provided written informed consent

Exclusion criteria

• Medical history of chemotherapy or endocrine therapy for breast cancer, or with treatment history of radiotherapy. Unwillingness to stop taking any drug known to affect sex hormone status (including hormone replacement therapy (HRT).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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197 participants in 2 patient groups

1

Active Comparator group

Description:

Tamoxifen

Treatment:

Drug: Tamoxifen

Drug: Goserelin acetate (Zoladex)

2

Experimental group

Description:

Anastrazole (Arimidex)

Treatment:

Drug: Goserelin acetate (Zoladex)

Drug: Anastrazole (Arimidex)